marbocare flavour 5mg Tablets for dogs and cats

marbocare flavour 5mg
®
Tablets for dogs and cats
Marbofloxacin
Statement of the active substances and other
ingredients
Fluoroquinolones should be reserved for the treatment of clinical
conditions which have responded poorly, or are expected to
respond poorly to other classes of antimicrobials. Whenever
Each tablet contains:
possible, use of fluoroquinolones should be based on
Active substance:
susceptibility testing. Use of the product deviating from the
Marbofloxacin
5.0mg
instructions given in the SPC may increase the prevalence of
Beige brown spotted round tablets with a score line on one side. bacteria resistant to the (fluoro)quinolones and may decrease
effectiveness of treatment with other quinolones due to the
Indications
potential for cross-resistance.
Marbofloxacin is indicated in the treatment of the following
Use during pregnancy, lactation or lay
infections caused by susceptible strains of organisms (see Other Studies in laboratory animals (rats, rabbits) showed no
Information section);
teratogenicity, embryotoxicity and maternotoxicity with
Dogs
marbofloxacin at therapeutic doses.
• Skin and soft tissue infections (skinfold pyoderma, impetigo,
The safety of marbofloxacin has not been assessed in pregnant and
folliculitis, furunculosis,cellulitis)
lactating dogs. Use only accordingly to the benefit/risk assessment
• Urinary tract infections (UTI) associated or not with prostatitis by the responsible veterinarian in pregnant and lactating animals.
or epididymitis
Interaction with other medicinal products and other forms
• Respiratory tract infections
of interaction
Cats
Fluoroquinolones are known to interact with orally administered
• Skin and soft tissue infections (wounds, abscesses, phlegmons) cations (Aluminium, Calcium, Magnesium, Iron). In such cases,
• Upper respiratory tract infections
the bioavailability may be reduced.
When administered together with theophylline, the half-life and
Contraindications
thus the plasma concentration of theophylline increases. Hence, in
Do not use in dogs aged less than 12 months, or less than 18
case of concurrent administration the dose of theophylline should
months for exceptionally large breeds of dogs, such as Great
be reduced.
Danes, Briard, Bernese, Bouvier and Mastiffs, with a longer
Overdose (symptoms, emergency procedures, antidotes),
growth period.
if necessary
Not recommended for use in cats aged less than 16 weeks.
Do not use in animals with known hypersensitivity to marbofloxacin Overdosage may cause acute signs in the form of neurological
disorders, which should be treated symptomatically.
or other (fluoro)quinolones or to any of the excipients.
User Warnings
Do not use in case of confirmed or suspected resistance to
People with known hypersensitivity to fluoroquinolones should
fluoroquinolones (cross resistance).
avoid using this product. In case of accidental ingestion seek
Adverse reactions
medical attention and show product label and/or package
Mild side effects such as vomiting, softening of faeces,
leaflet to the doctor. Wash hands after use.
modification of thirst or transient increase in activity may
Special
precautions for the disposal of
occasionally occur. These signs cease spontaneously after
treatment and do not necessitate cessation of treatment.
unused product or waste material, if any
If you notice any serious effects or other effects not mentioned in Any unused veterinary medicinal product or waste materials
this leaflet, please inform your veterinary surgeon.
derived from such veterinary medicinal products should be
disposed of in accordance with local requirements.
Target species
Dogs and cats.
Date on which the package leaflet was last
Dosage for each species, routes and
method of administration
For oral administration.
The recommended dose rate is 2mg/kg/day in a single daily
administration (see table below).
Body Weight (kg)
1.3 – 2.5
2.6 – 5.0
Tablets
1
2
To ensure a correct dosage body weight should be determined
as accurately as possible to avoid underdosing.
Dogs:
• In skin and soft tissue infections, treatment duration is at least
5 days. Depending on the course of the disease, it may be
extended up to 40 days.
• In urinary tract infections, treatment duration is at least 10
days. Depending on the course of the disease, it may be
extended up to 28 days.
• In respiratory infections, treatment duration is at least 7 days
and depending on the course of the disease, it may be
extended up to 21 days.
Cats:
• For skin and soft tissue infections (wounds, abscesses,
phlegmons) treatment duration is 3 to 5 days.
• For upper respiratory infections treatment duration is 5 days.
approved: 26.06.13
Other information
For animal treatment only.
Marbofloxacin is a synthetic, bactericidal antimicrobial,
belonging to the fluoroquinolone group which acts by inhibition
of DNA gyrase. It is effective against a wide range of Gram
positive bacteria (in particular Staphylococci,Streptococci) and
Gram negative bacteria (Escherichia coli, Salmonella
typhimurium, Citrobacter freundii, Enterobacter cloacae, Serratia
marcescens, Morganella morganii, Proteus spp, Klebsiella spp,
Shigella spp, Pasteurella spp, Haemophilus spp, Moraxella spp,
Pseudomonas spp, Brucella canis) as well as Mycoplasma spp.
Bacterial strains with a MIC ≤ 1μg/ml are susceptible, strains with
a MIC of 2μg/ml are intermediately susceptible and strains with a
MIC ≥ 4μg/ml are resistant to marbofloxacin (CLSI, 2004). MIC90
values of marbofloxacin for strains of Staphylococcus
(pseud)intermedius, Escherichia coli and Pasteurella multocida
isolated from diseased cats and dogs in Germany were 0.5μg/ml,
0.5μg/ml and 0.06μg/ml, respectively.
Resistance to fluoroquinolones occurs mostly by chromosomal
mutation with three mechanisms: decrease of the bacterial wall
permeability, expression of efflux pump or mutation of enzymes
responsible for molecule binding.
Marbofloxacin is not active against anaerobes, yeasts or fungi.
Pack sizes
Box containing 1 blister of 10 tablets (10 tablets)
Box containing 2 blisters of 10 tablets (20 tablets)
Keep out of the reach and sight of children. This veterinary medicinal Box containing 10 blisters of 10 tablets (100 tablets)
product does not require any special storage conditions. Do not use Not all pack sizes may be marketed.
after the expiry date stated on the blister and carton after “EXP”
Marketing Authorisation Holder: EMDOKA bvba, John Lijsenstraat 16,
B-2321 Hoogstraten, Belgium
Special warnings
Special precautions for use in animals
Manufacturer for the batch release: Lelypharma BV, Zuiveringsweg 42,
The fluoroquinolones have been shown to induce erosion of
8243 PZ Lelystad, The Netherlands
articular cartilage in juvenile dogs and care should be taken to
For any information about this veterinary medicinal product, please
dose accurately especially in young animals. However at the
contact the local representative of the marketing authorisation holder.
therapeutic recommended dosage, no severe side-effects are to Animalcare Ltd, 10 Great North Way, York, YO26 6RB, UK
be expected in dogs and cats.
Some fluoroquinolones at high doses may have an epileptogenic UK only:
IE only:
VPA 10534/004/001
Vm 34534/4003
potential. Cautious use is recommended in dogs and cats
POM
POM-V
diagnosed as suffering from epilepsy.
Prescription only medicine
To be supplied only on
A low urinary pH could have an inhibitory effect on the activity
veterinary prescription
of marbofloxacin.
Special storage precautions
LP1467
S.0813
Door goedkeuring van deze proef accepteert u de specificaties vermeld in dit kader.
Ons Ordernummer:
26519
Drukkleuren:
Artikelnummer klant:
LP1467
zwart
van Oldenbarneveldtstraat 116
Status:
S.0813
Fax 026 361 88 60
[email protected]
Pharmacode:
www.drukkerijleeflang.nl
Formaat:
150 x 280
Enkel/Dubbelzijdig:
1/0
Datum Proef: 03-09-13
Stansmesnr.:
Materiaal:
Anda
Gramsgewicht:
50
Vernis vrije ruimte:
Braille
Opmerkingen:
6827 AN Arnhem
Tel. 026 362 12 62
Bestand aangeleverd
Proefnr.:
1
Accoord klant:
Torben Orskov
Datum:
De kleuren van deze proef zijn slechts een indicatie. Beoordeel de kleuren op wat vermeld staat of met een PMS-waaier.
Digitally signed by Torben Orskov
DN: cn=Torben Orskov, o=Animalcare
Limited, ou, [email protected]
co.uk, c=GB
Date: 2013.09.04 18:43:49 +01'00'
`